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Federal Register / Vol. 71, No.

62 / Friday, March 31, 2006 / Rules and Regulations 16223

these three combination drug medicated List of Subjects in 21 CFR Part 558 § 558.78 Bacitracin zinc.
feeds. Animal drugs, Animal feeds. * * * * *
The NADAs are approved as of ■ Therefore, under the Federal Food, (d) * * *
February 15, 2006, and the regulations Drug, and Cosmetic Act and under
are amended in 21 CFR 558.76, 558.78, (3) * * *
authority delegated to the Commissioner
558.369, and 558.680 to reflect the (x) Nitarsone as in § 558.369.
of Food and Drugs and redelegated to
approval. Approval of these the Center for Veterinary Medicine, 21 * * * * *
supplemental NADAs did not require CFR part 558 is amended as follows:
review of any new safety or § 558.369 [Amended]
effectiveness data. Therefore, a freedom PART 558—NEW ANIMAL DRUGS FOR ■ 4. In § 558.369, amend paragraph
of information summary was not USE IN ANIMAL FEEDS (d)(2)(i) by adding ‘‘or bacitracin zinc’’
prepared. after ‘‘disalicylate’’.
The agency has determined under 21 ■ 1. The authority citation for 21 CFR
CFR 25.33(a)(2) that these actions are of part 558 continues to read as follows: ■ 5. In § 558.680, amend the table in
a type that do not individually or Authority: 21 U.S.C. 360b, 371. paragraph (d)(1)(i), after the entry for
cumulatively have a significant effect on ‘‘Arsanilic acid 90 (0.01%) plus
the human environment. Therefore, § 558.76 [Amended] penicillin 2.4 to 50’’ by adding entries
neither an environmental assessment ■ 2. In § 558.76, amend paragraph for ‘‘Bacitracin 4 to 50’’ and ‘‘Bacitracin
nor an environmental impact statement (d)(3)(xviii) by adding ‘‘or roxarsone’’ methylene disalicylate 4 to 50 plus
is required. after ‘‘arsanilic acid’’. roxarsone 22.7 to 45.4’’ to read as
This rule does not meet the definition ■ 3. In § 558.78, amend paragraph (d)(3)
follows:
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because by redesignating paragraphs (d)(3)(x) § 558.680 Zoalene.
it is a rule of ‘‘particular applicability.’’ through (d)(3)(xii) as paragraphs
* * * * *
Therefore, it is not subject to the (d)(3)(xi) through (d)(3)(xiii); and add
congressional review requirements in 5 new paragraph (d)(3)(x) to read as (d) * * *
U.S.C. 801–808. follows: (1) * * *

Zoalene in grams/ton Combination in grams/ton Indications for use Limitations

(i) * * *
Bacitracin 4 to 50 Replacement chickens: For development Feed as in subtable in § 558.680(d)(1)(i);
of active immunity to coccidiosis; for in- grower ration not to be fed to birds over
creased rate of weight gain, improved 14 weeks of age. As bacitracin meth-
feed efficiency ylene disalicylate provided by No.
046573 in § 510.600(c) of this chapter
Bacitracin methylene disa- Replacement chickens: For development Feed as in subtable in § 558.680(d)(1)(i);
licylate 4 to 50 plus of active immunity to coccidiosis; for in- grower ration not to be fed to birds over
roxarsone 22.7 to 45.4 creased rate of weight gain, improved 14 weeks of age. Discontinue use 5
feed efficiency, and improved pigmenta- days before slaughter; as sole source
tion of organic arsenic; drug overdose or
lack of water may result in leg weak-
ness. As bacitracin methylene disalicy-
late and roxarsone provided by No.
046573 in § 510.600(c) of this chapter

* * * * * * *

* * * * * DEPARTMENT OF HEALTH AND by Phibro Animal Health. One


Dated: March 22, 2006. HUMAN SERVICES supplemental NADA provides for the
use of fixed-combination Type A
Stephen F. Sundlof, Food and Drug Administration medicated articles containing
Director, Center for Veterinary Medicine. oxytetracycline and neomycin sulfate to
[FR Doc. 06–3122 Filed 3–30–06; 8:45 am] 21 CFR Part 558 formulate two-way fixed-combination
BILLING CODE 4160–01–S drug Type B and Type C medicated
[Docket No. 2003N–0324]
feeds for chickens, turkeys, swine,
New Animal Drugs for Use in Animal cattle, and sheep. Two of the
Feeds; Bacitracin; Nicarbazin; supplemental NADAs provide for the
Oxytetracycline and Neomycin; use of approved, single-ingredient Type
Penicillin A medicated articles containing
nicarbazin and penicillin, with or
AGENCY: Food and Drug Administration, without roxarsone, to formulate two-
HHS. way or three-way combination drug
ACTION: Final rule. Type C medicated feeds for broiler
chickens. The fourth supplemental
hsrobinson on PROD1PC61 with RULES

SUMMARY: The Food and Drug NADA provides for the use of approved,
Administration (FDA) is amending the single-ingredient Type A medicated
animal drug regulations to reflect articles nicarbazin, bacitracin methylene
approval of four supplemental new disalicylate, and roxarsone to formulate
animal drug applications (NADAs) filed three-way combination drug Type C

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16224 Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations

medicated feeds for broiler chickens. G PROCAINE (procaine penicillin) at fixed combination Type A medicated
These approvals reflect FDA’s 2.4 to 50 g/ton, and 3–NITRO article and three combination drug
effectiveness conclusions which relied (roxarsone) at 22.7 to 45.4 g/ton of feed medicated feeds.
on the National Academy of Sciences/ in broiler chickens as an aid in The supplemental NADAs are
National Research Council (NAS/NRC) preventing outbreaks of cecal (Eimeria approved as of February 15, 2006, and
Drug Efficacy Study Group’s evaluation tenella) and intestinal (E. acervulina, E. the regulations are amended in 21 CFR
of the effectiveness of these drugs when maxima, E. necatrix, and E. brunetti) 558.76, 558.460, and 558.366, and also
used in animal feed as single coccidiosis; for increased rate of weight in 21 CFR part 558 by adding new
ingredients. gain and improved feed efficiency; and § 558.455 to reflect these approvals.
DATES: This rule is effective March 31, for improved pigmentation. Approval of these supplemental NADAs
2006. Phibro Animal Health also filed a did not require review of any new safety
supplement to approved NADA 98–374 or effectiveness data. Therefore, a
FOR FURTHER INFORMATION CONTACT:
for use of nicarbazin and procaine freedom of information summary was
Andrew J. Beaulieu, Center for penicillin G Type A medicated articles
Veterinary Medicine (HFV–50), 7519 not prepared.
to formulate two-way combination drug The agency has determined under 21
Standish Pl., Rockville, MD 20855, 240– Type C medicated feeds. This
276–9090, e-mail: CFR 25.33(a)(2) that these actions are of
supplemental NADA provides for the a type that do not individually or
andrew.beaulieu@fda.hhs.gov. use of combination feeds containing cumulatively have a significant effect on
SUPPLEMENTARY INFORMATION: In the NICARBAZIN (nicarbazin) at 90.8 to the human environment. Therefore,
Federal Register of August 8, 2003 (68 181.6 g/ton and PENICILLIN G neither an environmental assessment
FR 47332), as corrected October 7, 2003 PROCAINE (procaine penicillin) at 2.4 nor an environmental impact statement
(68 FR 57919), as part of the Drug to 50 g/ton of feed in broiler chickens is required.
Efficacy Study Implementation (DESI) as an aid in preventing outbreaks of This rule does not meet the definition
program, CVM announced the effective cecal (Eimeria tenella) and intestinal (E. of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
conditions of use for several drug acervulina, E. maxima, E. necatrix, and it is a rule of ‘‘particular applicability.’’
products and use combinations listed in E. brunetti) coccidiosis; and for Therefore, it is not subject to the
21 CFR 558.15. CVM proposed to increased rate of weight gain and congressional review requirements in 5
withdraw the new animal drug improved feed efficiency. U.S.C. 801–808.
applications (NADAs) for those Phibro Animal Health also filed a
products or use combinations lacking supplement to approved NADA 100– List of Subjects in 21 CFR Part 558
substantial evidence of effectiveness 853 for use of nicarbazin, bacitracin Animal drugs, Animal feeds.
following a 90-day opportunity to methylene disalicylate, and roxarsone
■ Therefore, under the Federal Food,
supplement the NADAs with labeling single-ingredient Type A medicated
Drug, and Cosmetic Act and under
conforming to the relevant findings of articles to make three-way combination
authority delegated to the Commissioner
effectiveness. Phibro Animal Health, 65 drug Type C medicated feeds. This
of Food and Drugs and redelegated to
Challenger Rd., 3d Floor, Ridgefield supplemental NADA provides for the
the Center for Veterinary Medicine, 21
Park, NJ 07660, filed supplements to use of combination feeds containing
CFR part 558 is amended as follows:
four of its approved NADAs to revise NICARBAZIN (nicarbazin) at 90.8 to
the labeling of its products to comply 181.6 g/ton, BMD (bacitracin methylene PART 558—NEW ANIMAL DRUGS FOR
with these findings of effectiveness. disalicylate) at 4 to 50 g/ton, and 3– USE IN ANIMAL FEEDS
Phibro Animal Health filed a NITRO (roxarsone) at 22.7 to 45.4 g/ton
supplement to approved NADA 94–975 of feed in broiler chickens as an aid in ■ 1. The authority citation for 21 CFR
for NEO–TM 50/50D and NEO–TM 100/ preventing outbreaks of cecal (Eimeria part 558 continues to read as follows:
100D (oxytetracycline and neomycin tenella) and intestinal (E. acervulina, E. Authority: 21 U.S.C. 360b, 371.
sulfate) Type A medicated articles. The maxima, E. necatrix, and E. brunetti)
supplemental NADA provides for use of coccidiosis, and for increased rate of ■ 2. In § 558.76, revise paragraph
these fixed-combination Type A weight gain, improved feed efficiency, (d)(3)(xiii) to read as follows:
medicated articles to formulate two-way and improved pigmentation. § 558.76 Bacitracin methylene disalicylate.
fixed-combination drug Type B and The DESI evaluation is concerned
Type C medicated feeds containing * * * * *
only with the effectiveness of the drug
oxytetracycline and neomycin sulfate, products and use combinations. Nothing (d) * * *
in a 1:1 ratio, for several production and in this document constitutes a bar to (3) * * *
therapeutic indications in chickens, further proceedings with respect to (xiii) Nicarbazin alone or with narasin
turkeys, swine, cattle, and sheep. questions of safety of the subject drugs or roxarsone or with narasin and
Phibro Animal Health also filed a in treated animals or of the drugs or roxarsone as in § 558.366.
supplement to approved NADA 98–371 their metabolites in food products * * * * *
for use of nicarbazin, procaine derived from treated animals. ■ 3. In § 558.366, amend the table in
penicillin, and roxarsone single- Products that comply with FDA’s paragraph (d) after the entry for
ingredient Type A medicated articles to findings of effectiveness are eligible for ‘‘Narasin 27 to 45 and roxarsone 22.7 to
make three-way combination drug Type copying, as described in the Generic 45.4’’ by adding three entries to read as
C medicated feeds. This supplemental Animal Drug and Patent Term follows:
NADA provides for the use of Restoration Act Policy Letter Eight,
combination feeds containing August 21, 1991 (56 FR 41561). § 558.366 Nicarbazin.
hsrobinson on PROD1PC61 with RULES

NICARBAZIN (nicarbazin) at 90.8 to Accordingly, sponsors may now obtain * * * * *


181.6 grams per ton (g/ton), PENICILLIN approval of abbreviated NADAs for this (d) * * *

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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations 16225

Nicarbazin in grams Combination in Indications for use Limitations Sponsor


per ton grams per ton

* * * * * * *

90.8 to 181.6 (0.01 Bacitracin meth- Broiler chickens: As an aid in preventing Feed continuously as sole ration from 066104
to 0.02 pct) ylene disalicy- outbreaks of cecal (Eimeria tenella) time chicks are placed on litter until
late 4 to 50 and and intestinal (E. acervulina, E. maxi- past the time when coccidiosis is ordi-
roxarsone 22.7 ma, E. necatrix, and E. brunetti) coc- narily a hazard; do not use as a treat-
to 45.4 cidiosis, and for increased rate of ment for outbreaks of coccidiosis.
weight gain and improved feed effi- Feed as the sole source of organic ar-
ciency, and improved pigmentation senic; drug overdose or lack of water
may result in leg weakness; do not
use in flushing mashes. Discontinue
medication 5 days before marketing
the birds for human consumption to
allow for elimination of the drug from
edible tissue. Do not feed to laying
hens in production. Nicarbazin as pro-
vided by No. 066104; bacitracin meth-
ylene disalicylate and roxarsone by
No. 046573 in § 510.600(c) of this
chapter

Penicillin 2.4 to 50 Broiler chickens: As an aid in preventing Feed continuously as sole ration from 066104
outbreaks of cecal (Eimeria tenella) time chicks are placed on litter until
and intestinal (E. acervulina, E. maxi- past the time when coccidiosis is ordi-
ma, E. necatrix, and E. brunetti) coc- narily a hazard; do not use as a treat-
cidiosis, and for increased rate of ment for outbreaks of coccidiosis. Do
weight gain and improved feed effi- not use in flushing mashes. Do not
ciency feed to chickens producing eggs for
human consumption. Discontinue
medication 5 days before marketing
the birds for human consumption to
allow for elimination of the drug from
edible tissue. Penicillin as procaine
penicillin G. Nicarbazin and penicillin
as provided by No. 066104 in
§ 510.600(c) of this chapter

Penicillin 2.4 to 50 Broiler chickens: As an aid in preventing Feed continuously as sole ration from 066104
and roxarsone outbreaks of cecal (Eimeria tenella) time chicks are placed on litter until
22.7 to 45.4 and intestinal (E. acervulina, E. maxi- past the time when coccidiosis is ordi-
ma, E. necatrix, and E. brunetti) coc- narily a hazard; do not use as a treat-
cidiosis, and for increased rate of ment for outbreaks of coccidiosis.
weight gain and improved feed effi- Feed as the sole source of organic ar-
ciency, and improved pigmentation senic; drug overdose or lack of water
may result in leg weakness; do not
use in flushing mashes. Discontinue
medication 5 days before marketing
the birds for human consumption to
allow for elimination of the drug from
edible tissue. Do not feed to laying
hens in production. Penicillin as pro-
caine penicillin G. Nicarbazin and pen-
icillin as provided by No. 066104;
roxarsone by No. 046573 in
§ 510.600(c) of this chapter

* * * * * * *

■ 4. Add § 558.455 to read as follows: oxytetracycline hydrochloride and 50 g/ (b) Sponsors. See No. 066104 in
lb neomycin sulfate or oxytetracycline § 510.600(c) of this chapter.
§ 558.455 Oxytetracycline and neomycin.
equivalent to 100 g/lb oxytetracycline (c) Related tolerances. See §§ 556.430
(a) Specifications. Type A medicated hydrochloride and 100 g/lb neomycin and 556.500 of this chapter.
articles containing oxytetracycline sulfate. (d) Indications for use—(1) Chickens.
equivalent to 50 grams per pound (g/lb) It is used in feed as follows:
hsrobinson on PROD1PC61 with RULES

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16226 Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations

Oxytetracycline and
neomycin sulfate Indications for use Limitations Sponsors
amount in grams
per ton of feed

(i) 10 to 50 Chickens: For increased rate of weight gain and Feed continuously; do not feed to chickens pro- 066104
improved feed efficiency ducing eggs for human consumption

(ii) 100 to 200 Chickens: For control of infectious synovitis Feed continuously for 7 to 14 days (d); do not 066104
caused by Mycoplasma synoviae; control of feed to chickens producing eggs for human
fowl cholera caused by Pasteurella multocida consumption; in low calcium feed, withdraw 3
susceptible to oxytetracycline d before slaughter

(iii) 400 Chickens: For control of chronic respiratory dis- Feed continuously for 7 to 14 d; do not feed to 066104
ease (CRD) and air sac infection caused by chickens producing eggs for human consump-
M. gallisepticum and Escherichia coli suscep- tion; in low calcium feeds, withdraw 3 d be-
tible to oxytetracycline fore slaughter

(iv) 500 Chickens: For reduction of mortality due to air Feed continuously for 5 d; do not feed to chick- 066104
sacculitis (air-sac-infection) caused by E. coli ens producing eggs for human consumption;
susceptible to oxytetracycline withdraw 24 hours before slaughter; in low
calcium feeds withdraw 3 d before slaughter

(2) Turkeys. It is used in feed as


follows:

Oxytetracycline and
neomycin sulfate Indications for use Limitations Sponsors
amount

(i) 10 to 50 g/ton of Growing turkeys: For increased rate of weight Feed continuously; do not feed to turkeys pro- 066104
feed gain and improved feed efficiency ducing eggs for human consumption

(ii) 100 g/ton of Turkeys: For control of hexamitiasis caused by Feed continuously for 7 to 14 d; do not feed to 066104
feed Hexamita meleagridis susceptible to oxytetra- turkeys producing eggs for human consump-
cycline tion

(iii) 200 g/ton of Turkeys: For control of infectious synovitis Feed continuously for 7 to 14 d; withdraw 5 d 066104
feed caused by M. synoviae susceptible to oxytet- before slaughter; do not feed to turkeys pro-
racycline ducing eggs for human consumption

(iv) To provide 25 Turkeys: For control of complicating bacterial or- Feed continuously for 7 to 14 d; withdraw 5 d 066104
mg/lb of body ganisms associated with bluecomb (trans- before slaughter; do not feed to turkeys pro-
weight daily missible enteritis; coronaviral enteritis) sus- ducing eggs for human consumption
ceptible to oxytetracycline

(3) Swine. It is used in feed as follows:

Oxytetracycline and
neomycin sulfate Indications for use Limitations Sponsor
amount

(i) 10 to 50 g/ton of Swine: For increased rate of weight gain and improved feed effi- 066104
feed ciency

(ii) To provide 10 mg/ 1. Swine: For treatment of bacterial enteritis caused by E. coli and Feed continuously for 7 to 066104
lb of body weight Salmonella choleraesuis and treatment of bacterial pneumonia 14 d; withdraw 5 d be-
daily caused by P. multocida susceptible to oxytetracycline; treatment fore slaughter
and control of colibacillosis (bacterial enteritis) caused by E. coli
susceptible to neomycin
2. Breeding swine: For control and treatment of leptospirosis (re- Feed continuously for not 066104
ducing the incidence of abortion and shedding of leptospirae) more than 14 d; with-
caused by Leptospira pomona susceptible to oxytetracycline draw 5 d before slaugh-
ter

(4) Cattle and sheep. It is used in feed


hsrobinson on PROD1PC61 with RULES

as follows:

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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations 16227

Oxytetracycline and
neomycin sulfate Indications for use Limitations Sponsor
amount

(i) 10 to 20 grams Sheep: For increased rate of weight 066104


per ton of feed gain and improved feed efficiency

(ii) To provide 0.05 Calves (up to 250 lb): For increased Feed continuously; in milk replacers or starter feed 066104
to 0.1 mg/lb of rate of weight gain and improved
body weight feed efficiency
daily.

(iii) To provide 10 1. Calves and beef and nonlactating Feed continuously for 7 to 14 d; in feed or milk replac- 066104
mg/lb of body dairy cattle: For treatment of bacterial ers. If symptoms persist after using for 2 or 3 d, con-
weight daily enteritis caused by E. coli and bac- sult a veterinarian. Treatment should continue 24 to 48
terial pneumonia (shipping fever hours beyond remission of disease symptoms. A with-
complex) caused by P. multocida drawal period has not been established for use in
susceptible to oxytetracycline; treat- preruminating calves. Do not use in calves to be proc-
ment and control of colibacillosis essed for veal. A milk discard time has not been es-
(bacterial enteritis) caused by E. coli tablished for use in lactating dairy cattle. Do not use in
susceptible to neomycin female dairy cattle 20 months of age or older. With-
draw 5 d before slaughter
2. Calves (up to 250 lb): For treatment Feed continuously for 7 to 14 d; in milk replacers or 066104
of bacterial enteritis caused by E. coli starter feed. If symptoms persist after using for 2 or 3
susceptible to oxytetracycline; treat- d, consult a veterinarian. Treatment should continue
ment and control of colibacillosis 24 to 48 hours beyond remission of disease symp-
(bacterial enteritis) caused by E. coli toms. A withdrawal period has not been established for
susceptible to neomycin use in preruminating calves. Do not use in calves to
be processed for veal. A milk discard time has not
been established for use in lactating dairy cattle. Do
not use in female dairy cattle 20 months of age or
older. Withdraw 5 d before slaughter
3. Sheep: For treatment of bacterial en- Feed continuously for 7 to 14 d. If symptoms persist after 066104
teritis caused by E. coli and bacterial using for 2 or 3 d, consult a veterinarian. Treatment
pneumonia caused by P. multocida should continue 24 to 48 hours beyond remission of
susceptible to oxytetracycline; treat- disease symptoms. Withdraw 5 d before slaughter
ment and control of colibacillosis
(bacterial enteritis) caused by E. coli
susceptible to neomycin

(iv) To provide 25 Calves (250 to 400 lb): For increased 066104


mg/head/day rate of weight gain and improved
feed efficiency

(v) To provide 75 Growing cattle (over 400 lb): For in- 066104
mg/head/day creased rate of weight gain; im-
proved feed efficiency, and reduction
of liver condemnation due to liver ab-
scesses

(vi) To provide 0.5 Cattle: For prevention and treatment of Feed 3 to 5 d before and after arrival in feedlots. A with- 066104
to 2.0 g/head/day the early stages of shipping fever drawal period has not been established for use in
complex preruminating calves. Do not use in calves to be proc-
essed for veal. A milk discard time has not been es-
tablished for use in lactating dairy cattle. Do not use in
female dairy cattle 20 months of age or older

■ 5. In § 558.460, redesignate Dated: March 22, 2006. DEPARTMENT OF HEALTH AND


paragraphs (d)(2)(vi), (d)(2)(vii), and Stephen F. Sundlof, HUMAN SERVICES
(d)(2)(viii) as paragraphs (d)(2)(iii), Director, Center for Veterinary Medicine.
(d)(2)(v), and (d)(2)(vi); and add new Food and Drug Administration
[FR Doc. 06–3120 Filed 3–30–06; 8:45 am]
paragraph (d)(2)(iv) to read as follows: BILLING CODE 4160–01–S
21 CFR Parts 814 and 820
§ 558.460 Penicillin.
* * * * * [Docket No. 2006N–0127]
(d) * * *
Medical Device Reporting; Premarket
(2) * * *
hsrobinson on PROD1PC61 with RULES

Approval of Medical Devices; Quality


(iv) Nicarbazin alone or with System Regulation; Technical
roxarsone as in § 558.366. Amendment
* * * * * AGENCY: Food and Drug Administration,
HHS.

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